Supervisor, Quality Assurance - Pkg

Supervises the approval or rejection of components, labeling, in-process material, and finished products. Reviews production records to assure material meets specifications. Investigates and documents errors which occur during production. Ensures adherence with cGMPs, SOPs, state and local regulations, in addition to customer specific requirements.Operational - Supervises the approval (releases) and rejections of components and finished product. Supervises the required Material Resource Planning (MRP) transactions for approvals, releases, quarantines, and rejections. Ensures that line inspection and in-process checks are properly conducted. Conducts and/or assists in investigations concerning operational problems and/or problems involving customer complaints. Departmental/Shift Administration - Schedules the work assignments for the department/shift. Sets challenging yet achievable goals for staff. Helps staff to build upon their capabilities and encourages others to achieve results. Responsible for the training and motivation of the department. Maintains open lines of communications with department. Provides input into department budget, as needed. Conducts performance evaluations with the assistance of department management. Stays abreast of developments in the field through own study as well as attendance of various seminars and workshops. Recommends objectives and department goals. Functional Administration - Conducts periodic plant audits for strict adherence to cGMPs and SOPs. Assists with the training of plant personnel in GMPs. Helps to develop SOPs. Oversees the maintenance of the retain sample program environmental monitoring, and settling plate (micro) monitoring programs.Continuously reviews efficiency opportunities within the daily workflow and recognizes the need for new or modified work procedures. Seeks out and uses new tools, processes, and procedures to add value to the company. Anticipates issues and works proactively to resolve problems.Performs other related duties as assigned by management. Some travel required, such as vendor audits, seminars, and site visits.

Bachelor's Degree in a Life or Physical Science is required. Must have a working knowledge of cGMP and regulatory guidelines.5 years experience in a laboratory plant Quality Assurance setting, plus one year lead experience in a pharmaceutical/HBA manufacturing environment. Prefer 1 year of supervisory experience.PC and mainframe literacy required. Good verbal and written communication skills required. Must effectively communicate cross functionally with peers, associates, and upper level management. Able to writer and ensure technical content is correct. Ability to work independently and in a team environment. ASQ - CQA preferred.

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